NewAmsterdam Pharma Company (NAMS) Status Update summary

Key trial results and efficacy

• BROADWAY phase 3 trial showed Obicetrapib monotherapy reduced LDL-C by 33–40%, and the fixed-dose combination with ezetimibe achieved up to 50% reduction, both highly statistically significant versus placebo.

• Over half of patients on Obicetrapib reached LDL-C <55 mg/dL, a five-fold increase over placebo, and over two-thirds achieved <70 mg/dL.

• Obicetrapib demonstrated rapid, durable LDL-C lowering and consistent efficacy across all phase 2 and 3 trials, including BROOKLYN and BROADWAY.

• The drug also robustly lowered ApoB, Lp(a), small LDL particles, and improved glycemic measures linked to high CV risk.

• The trial population was diverse, with robust global representation, including ASCVD or HeFH patients with baseline LDL-C ~100 mg/dL.

Cardiovascular outcomes and safety

• BROADWAY showed a 21% reduction in first four-point MACE at one year (HR 0.79), with consistent benefit across all MACE components.

• Pooled BROADWAY + BROOKLYN data showed a 25% relative risk reduction in MACE (HR 0.75).

• Kaplan-Meier curves separated after six months, indicating early and durable cardiovascular benefit.

• Safety profile was favorable, with adverse events and discontinuation rates comparable or lower than placebo, and no significant safety signals, including for new-onset diabetes or renal function.

• Statistically significant 5% absolute reduction in new-onset diabetes and improved glycemic control, despite high-intensity statin background.

Trial design and population

• BROADWAY was a 52-week, global, double-blind, placebo-controlled phase 3 trial in 2,530 ASCVD/HeFH patients not at LDL-C goal despite maximal therapy.

• 2:1 randomization to 10 mg obicetrapib or placebo, with 94% completing the trial.

• Baseline: 76% had ASCVD, 17% HeFH, 38% diabetes; 91% on statins, 27% on ezetimibe, 4% on PCSK9i.

• Mean age was 65 years, 34% female, BMI ~30 kg/m²; diverse global enrollment.

• Primary endpoint was LDL-C at 12 weeks; MACE was exploratory.